07.Feb.2018

Changes to clinical trials of medical devices

The Ministry of Healthcare of the Russian Federation adjusts requirements for organizations conducting clinical trials of medical devices.

Pharmvestnik reports that the Ministry of Healthcare has started discussing the draft order “On Introduction of Amendments to Order No. 300n of the Ministry of Healthcare of the Russian Federation of May 16, 2013 “On Approval of Requirements for Medical Organizations Conducting Clinical Trials of Medical Devices and the Procedure of Assessing Organizations’ Compliance with these Requirements”.

The changes will affect the list of requirements for organizations conducting clinical trials of medicinal products and organizations conducting clinical trials for in vitro diagnostics.